Hemodialysis in the Elderly (70yrs & Older)

NCT03065972 | Unknown DMC

• 1 other identifier: Pro00013220
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a prospective, single institution, parallel-group, single-blinded, randomized-controlled, two-arm, effectiveness study comparing autologous arteriovenous fistula versus hemodialysis access grafts in the elderly. The target sample size will include enrollment of 270 patients over a period of 5 years. The creation of an autologous arteriovenous fistula or placement of a hemodialysis access graft constitutes the two arms of the study.

Conditions

Kidney Disease; Kidney Failure; Chronic Kidney Disease

Keywords

kidney disease; vascular access; graft; fistula; hemodialysis; dialysis

Outcome Measures

Primary Outcomes (2)

• Analyze hemodialysis (HD) access creation, arteriovenous (AV) fistula vs Graft, in elderly patients.

  Assess frequency of HD access use, abandonment, and patency at 12 months post-procedure. We will communicate with the patient every month from date of surgery until 12 months to complete questionnaires to determine access use and patency for their study related access creation

  12 months

• Functional cumulative patency rate at 12 months

  Functional refers to the availability of the access for hemofiltration. Primary patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention

  12 months

Secondary Outcomes (4)

• Using Disease Outcomes Quality Initiative quality of life tool to evaluate and compare the overall improvement in outcome with respect to morbidity in the 2 years post fistula/graft procedure

  2 years

• To compare and analyze the estimated costs with both types of hemodialysis interventions and their postoperative outcomes.

  2 years

• Using Disease Outcomes Quality Initiative quality of life tool to evaluate and compare the overall improvement in outcome with respect to mortality in the 2 years post fistula/graft procedure

  2 years

• Using Disease Outcomes Quality Initiative quality of life tool to evaluate and compare the overall improvement in outcome with respect to patient's quality of life in the 2 years post fistula/graft procedure

  2 years

Study Arms (2)

Surgical fistula creation from patient's anatomy

ACTIVE COMPARATOR

Patients randomized to surgical arteriovenous fistula will have a fistula surgically created from their anatomy to be used for hemodialysis access.

Procedure: Surgical fistula creation from patient's anatomy

Surgical graft implant

ACTIVE COMPARATOR

Patients randomized to surgical graft, will have a commercially available graft surgically implanted to be used for hemodialysis access.

Procedure: Surgical fistula creation from patient's anatomy; Device: Surgical Graft implant

Interventions

Surgical fistula creation from patient's anatomy PROCEDURE

Patient will be randomized via computer system, to receive the fistula or graft. If fistula, surgeon creates fistula for hemodialysis access from patient's anatomy.

Also known as: Fistula

Surgical fistula creation from patient's anatomy; Surgical graft implant

Surgical Graft implant DEVICE

Patient will be randomized via computer system, to receive the fistula or graft. If graft, surgeon implants hemodialysis access using an FDA approved graft.

Also known as: FDA approved graft (various manufacturers)

Surgical graft implant

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Aged ≥70 years of all ethnicities, and;
• Have vascular anatomy amenable to arteriovenous fistula creation, and;
• Diagnosed with End-stage Renal Disease stage 4 (GFR 15-29 ml/min 1.73m2) or stage 5 (GFR \<15ml/min 1.73m2) as per the National Kidney Foundation guidelines needing vascular access for hemodialysis; or,
• Currently undergoing hemodialysis with a failure of previous access; or,
• Expected to undergo hemodialysis within 6 months of presentation.

You may not qualify if:

• Unable or refuse to abide with follow-up; or,
• Known hypercoagulability syndrome or a bleeding disorder; or,
• Intraoperative decision was made in favor of fistula instead of graft; or,
• Active infections; or,
• Evidence or suspicion of central vein stenosis but shall be included if a central vein catheter or pacemaker is implanted as long as the patient had a venogram within past 6 months.

Sponsors & Collaborators

• E. Peden, MD: lead
• The Methodist Hospital Research Institute: collaborator

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Kidney Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Fistula

Interventions

Portacaval Shunt, Surgical

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, Surgical; Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures

Study Officials

• Eric K Peden, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bright Benfor, MD

CONTACT

713-441-0147; bbenfor@houstonmethodist.org

Bevin A Lopez, MS,CEP,CCRP

CONTACT

346-320-7421; balopez@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator/Principal Investigator

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: February 28, 2017
• Study Start: January 28, 2016
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Available for 5 years upon study completion
• Access Criteria: After publication of results, de-identified participant data can be made available upon reasonable request to the Primary Investigator

Locations

US (1)